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WHO 152nd Session of the Executive Board - Item 11 - Standardization of medical devices nomenclature - EU Statement

03.02.2023 Press and information team of the Delegation to the UN in Geneva

Chair,

Director-General,

Excellencies,

Colleagues,

This statement is made on behalf of the EU and its Member States.

The candidate countries North Macedonia, Montenegro, Ukraine, Republic of Moldova and Bosnia and Herzegovina[1] and the EFTA country Norway align themselves with this statement.

The EU and its Member States thank the Director-General and the Secretariat for the report EB152/11 and for the excellent and hard work done by our colleagues in the involved WHO departments and units in this context, such as

  • the update of the Global atlas of medical devices as well as of
  • the Global model regulatory framework,
  • the successful selection of a provider to provide mapping of medical devices nomenclature data for integration into WHO platforms,
  • the recently performed update of MEDEVIS and finally
  • the establishment of the WHO Strategic and Technical Advisory Group on Medical Devices.

We welcome the continuation of the mapping between the relevant nomenclature systems as well as the planned conclusion of memoranda of understanding with the holders of the nomenclature systems EMDN, GMDN, UMDNS and UNSPS.

The European Union and its Member States further recall that the EMDN is a clear, transparent, free nomenclature that is available to all States and which meets the criteria for global public goods.

Looking ahead to the next steps to take, we invite the Secretariat to specify its timeline as to the different deliverables in this field and to make this information available to the Member States.

Finally, we urge the Director-General to allocate sufficient resources to the services assigned with theses challenging tasks in order to ensure a timely and smooth implementation and to guarantee sustainability for the following years.

 

[1] North Macedonia, Montenegro and Bosnia and Herzegovina continue to be part of the Stabilisation and Association Process.